Current practice of darbepoetin alfa in the management of haemoglobin levels in cancer patients undergoing chemotherapy – data from the CHOICE study

Abstract

Objective:

To evaluate adherence to European Organisation for Research and Treatment of Cancer (EORTC) and European Summary of Product Characteristic (SmPC) guidance on recommended haemoglobin (Hb) values in routine clinical practice use of darbepoetin alfa (DA) in cancer patients internationally.

Methods:

This multicentre, prospective, observational study assessed DA use in 11 European countries. This interim analysis (IA) included ∼1300 breast, colorectal, ovarian or lung cancer patients receiving DA during any chemotherapy cycle. Hb level and red blood cell (RBC) transfusion requirement data were collected.

Results:

Of the 1290 patients (mean [SD] age 62.5 [11.1] years) included in this IA full analysis set, 499 had lung, 387 breast, 192 colorectal and 212 ovarian cancer. Mean baseline Hb levels were <10 g/dL. At week 9, 426 (33%) patients had a Hb level of 10–12 g/dL, 165 (13%) of >12 g/dL, 226 (18%) of <10 g/dL and 473 (37%) had missing Hb values. 54% of the 672 patients still on the study at week 9 with available Hb values had Hb values of 10–12 g/dL. For patients with a baseline Hb of <10 g/dL, the Kaplan–Meier (K–M) percentage of patients with Hb levels ≥10 g/dL from week 1 to end of treatment period (EOTP) was 86%. For these patients, the K–M% of patients with Hb levels >13 g/dL from week 1 to EOTP was 10%. The K–M% of patients requiring RBC transfusions from week 5 to EOTP was 26% for all patients. Seven patients reported treatment-related non-serious adverse drug reactions, four were thromboses.

Conclusions:

This IA suggests most patients were treated according to European SmPC guidance. Hb evolution during the study is consistent with data from clinical trials, implying DA is effective in increasing Hb levels in chemotherapy-induced anaemia patients. Hb levels >13 g/dL were infrequent. Limitations are related to the observational nature of this study.

Key words::

• Chemotherapy-induced anaemia
• Darbepoetin alfa
• European summary of product characteristics (SmPC)
• Haemoglobin
• Red blood cell transfusion
• Routine clinical practice

Transparency

Declaration of funding

This study was supported by Amgen (Europe) GmbH.

Declaration of financial/other relationships

S.V.B., C.K., J.-L.L. and A.G. have disclosed that they were investigators of this study. S.V.B. has also disclosed that he is a consultant for Amgen Belgium SA/NV. T.W. and B.P. have disclosed that they are employees of Amgen (Europe) GmbH.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors thank the patients who participated in this study and the medical staff of each centre. We would also like to thank the people who helped in the preparation of this manuscript, in particular archimed medical communication ag for their writing support (funded by Amgen [Europe] GmbH).

Preliminary data of the CHOICE study were presented at:

1. ECIM (European Congress for Integrative Medicine), 20–21 November 2009, Berlin Germany: Van Belle S, Dalivoust P, Reinthaller A, Tzanninis D, Urbański K, Hamilton L and Pujol B. 2009. CHOICE, an international, observational study to examine current practice use of darbepoetin alfa in the management of chemotherapy-induced anaemia. Eur J Integrative Med 2009;1:226.

2. SIOG (meeting of the International Society of Geriatric Oncology), 15–17 October 2009, Berlin Germany: Van Belle S, Dalivoust P, Reinthaller A, Tzanninis D, Urbański K, Hamilton L and Pujol B. 2009. Current practice use of darbepoetin alfa in the management of chemotherapy-induced anaemia in patients <65 and ≥65 years: interim data from CHOICE, an international, observational study. Crit Rev Oncol Hematol 2009;72:S51-S52.

3. ESMO (European Society for Medical Oncology), 8–12 October 2010, Milan, Italy: Van Belle S, Urbański K, Orfeuvre H, Foucher P, Wheeler T, Pujol B. Darbepoetin alfa dosing weekly and every three weeks in cancer patients with chemotherapy-induced anaemia – efficacy data from the CHOICE study. Ann Oncol 2010;21(S8):viii-386.

4. ASCO-GI (American Society of Clinical Oncology – Gastrointestinal Cancer Symposium), 20–22 January 2011, San Francisco USA: Van Belle S, Urbański K, Orfeuvre H, Foucher P, Wheeler T, Pujol B. Efficacy of darbepoetin alfa in colorectal cancer patients: Data from the CHOICE study. J Clin Oncol 2011;29(S4):abstr 552